510(k) K243241
- Device
- Phasix ST Umbilical Hernia Patch
- Applicant
- Davol, Inc., A Subsidiary of C.R. Bard, Inc.
- 510(k) number
- K243241
- Product code
- OWT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-02-19
- Date received
- 2024-10-10
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Absorbable, Abdominal Hernia
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Shannon Green
- Address
- 100 Crossings Blvd. Warwick RI US 02886 02886
FDA Registration Numbers
- 3009337401
- 3009514842
- 3006174295
- 3010187263
- 3006082230
- 1223089
- 1319639
- 3003910212
- 9615742
- 1213643
- 3005636544
- 3010383847
Source Documents
Other 510(k) Records For Product Code OWT
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233661 | Transorb™ Self-Gripping Resorbable Mesh | Sofradim Production | 2024-02-13 |
| K191749 | TIGR Matrix Surgical Mesh, TIGR Surgical Mesh | Novus Scientific AB | 2020-03-26 |
| K191773 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | 2019-07-31 |
| K190185 | Phasix ST Mesh with Open Positioning System | C.R. Bard, Inc. | 2019-06-12 |
| K173143 | Phasix ST Mesh | C.R. Bard, Inc. | 2018-04-25 |
| K163005 | TIGR Matrix Surgical Mesh | Novus Scientific AB | 2017-07-27 |
| K143380 | Phasix ST Mesh | C.R. Bard, Inc. | 2015-06-05 |
| K120728 | PHASIX PLUG AND PATCH | C.R. Bard, Inc. | 2012-10-22 |
| K101287 | TEPHAFLEX COMPOSITE MESH | Tepha, Inc. | 2010-08-30 |
| K033671 | GORE BIOABSORBABLE MESH | W. L. Gore & Associates, Inc. | 2003-12-31 |